Financial Performance and Capital Requirements - The company has incurred significant net losses since inception and is expected to continue incurring substantial net losses for the foreseeable future[21] - The company requires substantial additional capital to finance operations, and failure to raise such capital may force delays or reductions in research and drug development programs[21] - The company may face increased regulatory costs and compliance requirements in drug development, impacting financial performance[17] - The company is subject to ongoing regulatory obligations and continued review, which may result in significant additional expenses[22] Operational Risks - The company relies on third-party manufacturing and supply vendors, which may lead to limitations or interruptions in the supply of development materials[21] - The market opportunities for the company's product candidates may be relatively small, targeting patients ineligible for or who have failed prior treatments[21] - The company has identified material weaknesses in internal control over financial reporting, which could affect the accuracy of financial condition reporting[22] - The company has entered into agreements that may impose obligations, and failure to comply could result in loss of important rights[21] Stock and Securities - The company is classified as an "emerging growth company," which may make its securities less attractive to investors[22] - The company may experience volatility in stock price and warrants, posing risks to investors[22] - Each new non-employee director is granted a one-time stock option to purchase 75,000 shares at a strike price of $10.00 per share[884] - The estimated fair value of the stock options on the grant date was $3.73 per share, resulting in stock-based compensation expenses of $0.7 million for fiscal year 2024 and $0.6 million for fiscal year 2023[885] - The Backstop Put Option Liability has an estimated future stock price range of $0.17 to $0.55, with an expected volatility of 147.5% and a risk-free rate of 4.17%[890] - The 2024 Convertible Note has an estimated volatility of 55%, a risk-free rate of 4.37%, and a probability range of 0% to 65%[892] - The SPA Warrants have an estimated volatility of 115%, a risk-free rate of 4.29%, and a probability range of 0% to 65%[892] - The fair value of the Ayrton Note Purchase Option was determined to be zero as of December 31, 2024, and 2023[893] Company Structure and Reporting - The company operates as one reportable segment focused on discovering and developing therapeutic products in oncology, fibrosis, infectious diseases, and inflammation[895] - The company has no off-balance sheet arrangements during the periods presented[896] - The company adopted ASU 2020-06 effective January 1, 2023, which simplifies accounting for convertible instruments[897] - The company is classified as a "smaller reporting company" with an expected market value of stock held by non-affiliates less than $700 million and annual revenue below $100 million[901]

PROVIDENCE, R.I., March 28, 2025 (GLOBE NEWSWIRE) -- Ocean Biomedical, Inc. (NASDAQ: OCEA), a biopharmaceutical company dedicated to advancing innovative treatments for cancer, infectious diseases, and fibrosis, today announced that the China National Intellectual Property Administration (CNIPA) has granted a notice of grant on patent right for its bispecific antibodies targeting CHI3L1 and PD1, designed to enhance T cell-mediated cytotoxic effects on tumor cells. This newly issued patent will strengthen Oc ...

PROVIDENCE, R.I., March 28, 2025 (GLOBE NEWSWIRE) -- Ocean Biomedical, Inc. (NASDAQ:OCEA), a biopharmaceutical company dedicated to advancing innovative treatments for cancer, infectious diseases, and fibrosis, today announced that the China National Intellectual Property Administration (CNIPA) has granted a notice of grant on patent right for its bispecific antibodies targeting CHI3L1 and PD1, designed to enhance T cell-mediated cytotoxic effects on tumor cells. This newly issued patent will strengthen Oce ...

Company Overview - Ocean Biomedical has announced research findings showing its cancer immunotherapy candidates can synergize with tyrosine kinase inhibitors (TKIs) like osimertinib, which are used for treating non-small cell lung cancer (NSCLC) [1][2] - The proprietary candidates have demonstrated the ability to restore treatment sensitivity after resistance to osimertinib develops, indicating a potential shift in treatment paradigms for EGFR-mutant NSCLC [1][2] Research and Development - The research, led by Dr. Jack A. Elias in collaboration with Yale and Brown University, highlights the role of chitinase 3-like-1 (CHi3L1) in EGFR-mutant cancers and the ability of Ocean's antibody to suppress CHi3L1 activity, resulting in significant tumor reduction [2] - Ocean Biomedical is initiating preclinical studies to advance its immunotherapy program and plans to engage with the FDA to establish a regulatory pathway for first-in-human trials [3][10] Industry Context - The oncology field is increasingly focusing on bispecific antibodies, which target multiple cancer mechanisms simultaneously, with significant investments from leading biotech and pharmaceutical companies [4][5] - Merck's acquisition of LaNova's LM-299 for $588 million, a PD-1/VEGF bispecific antibody, underscores the high-value potential of this technology, suggesting a significant opportunity for Ocean Biomedical [5] Product Development - Ocean has developed bispecific antibodies that combine its anti-CHI3L1 antibody with anti-PD-1 or anti-CTLA4, showing impressive efficacy in preclinical models for NSCLC, malignant melanoma, and glioblastoma [6] - The company's lead oncology program is positioned for multiple therapeutic applications, including as a standalone therapy for EGFR-mutant NSCLC, in combination with existing TKIs, and as a salvage therapy for resistant tumors [9] Strategic Positioning - Ocean Biomedical's Board Chair, Dr. Chirinjeev Kathuria, emphasized the company's strategic positioning to capitalize on the shift towards next-generation bispecific antibodies, which could drive significant value for patients and investors [7]

Providence, RI, Jan. 29, 2025 (GLOBE NEWSWIRE) -- Ocean Biomedical (NASDAQ: OCEA) announced today that its Scientific Co-founder, Dr. Jonathan Kurtis, MD, PhD, and his research team have received additional significant funding from the National Institutes of Health (NIH) to advance their groundbreaking malaria vaccine research. In parallel, recent U.S. Food and Drug Administration (FDA) Guidance on lipid-encapsulated vaccines may offer an expedited development pathway for their innovative approach. Malaria ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission File Number: 001-40793 OCEAN BIOMEDICAL, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 87-1309280 55 ...

Financial Performance and Losses - Net loss for the three months ended June 30, 2024, was $17.234 million, compared to $11.431 million for the same period in 2023[390] - Net loss per common share for the three months ended June 30, 2024, was $0.63, compared to $0.43 for the same period in 2023[390] - The company's net loss for the six-month period ended June 30, 2024 was $17,234, contributing to an accumulated deficit of $200,290[59] - Net loss for the three months ended June 30, 2024, was $17.234 million, compared to $11.431 million in the same period in 2023[65] - Total operating expenses for the three months ended June 30, 2024, were $682 thousand, down from $2,832 thousand in the same period in 2023[65] Equity and Stock Issuances - The company issued 13,257 shares of common stock with a fair value of $83 thousand as consideration for a Marketing Services Agreement in Q2 2023[383] - The company had 34,868,628 shares of common stock outstanding as of June 30, 2024[5] - The company's weighted-average shares of common stock outstanding for the three months ended June 30, 2024, were 27,487,283[390] - The company issued warrants for 511,712 shares of common stock at an exercise price of $8.06 per share and 102,342 shares at $7.47 per share[226] - The company has 600,000 stock options outstanding as of June 30, 2024, with a weighted average exercise price of $10.00 and a remaining contractual life of 1.7 years[55] Licensing and Agreements - The company must raise at least $10.0 million in equity financing by May 1, 2024, to avoid termination of certain license agreements[391] - The company recorded annual license maintenance fees of $12,000 for the six-month periods ended June 30, 2024, and 2023[397] - As of June 30, 2024, the company had $0.1 million in accrued expenses related to license fees[397] - The company entered into an amendment with Virion in September 2024, agreeing to contribute $9.0 million in cash and/or shares to increase its ownership interest to 22%[412] Debt and Financing - The Company received a notice of default for $2.1 million, including $1.6 million in unpaid principal and $0.5 million in accrued interest[413] - The principal amount of the Existing Note is $9.7 million, including Event of Default Interest and Redemption Premium[418] - The Company's available cash must equal or exceed $3.0 million at each Additional Closing, and the ratio of outstanding principal to market capitalization must not exceed 35%[208] - The Company entered into a Securities Purchase Agreement for up to $27.0 million in Senior Secured Convertible Notes, with an initial note of $7.6 million[200] - The principal amount outstanding under the 2023 Convertible Note was $7.6 million as of June 30, 2024[201] - The Company is required to pay $0.5 million and $1.2 million towards outstanding loans upon the first and second Additional Closings, respectively[204] - The Company recognized $0.1 million and $0.2 million of interest expense on the McKra Loan for the three and six months ended June 30, 2024, respectively[205] - The Company borrowed $0.7 million under the March Second Street Loan with a 15% interest rate[190] - The Company is required to pay $0.5 million towards outstanding loans upon certain closings[195] - The company borrowed $1.0 million from McKra Investments III in March 2023, with a 15% annual interest rate and a $0.2 million loan fee[193] - The company recognized $0.1 million in interest expense on Second Street Loans for the three months ended June 30, 2024, compared to $0.3 million in the same period in 2023[192] Investments and Acquisitions - The Company acquired a 50% membership interest in Virion for an initial contribution of $4.1 million or 750,000 shares of common stock[40] - The Company increased the liability for the post-closing true-up to $3.2 million and recorded a $1.9 million expense for the change in fair value of the Virion Contribution Liability[40] - Virion incurred a net loss of $1.1 million for the three-month period and $5.6 million for the six-month period ended June 30, 2024, with the company recording its share of the loss as $0.6 million and $2.8 million respectively[41] - The company acquired all outstanding capital stock of Legacy Ocean for approximately $240.0 million in aggregate consideration before transaction and other fees[85] Revenue and Expenses - The company has not generated any revenue since its inception and does not expect to generate revenue from product sales in the foreseeable future[95] - Research and development expenses for the three and six months ended June 30, 2024 included costs for stock-based compensation, initial license fees, annual maintenance license fees, and services agreements[104] - The company incurred $0.1 million in reimbursed patent costs for the six months ended June 30, 2024, down from $0.2 million in the same period in 2023[229] - Stock-based compensation expense for the three-month and six-month periods ended June 30, 2024 was $0.2 million and $0.4 million respectively[54] Cash and Liquidity - The company had minimal cash or cash equivalents as of June 30, 2024 and December 31, 2023[100] - Net cash used in operating activities for the six-month period ended June 30, 2024 was $775, compared to $7,433 in the same period in 2023[71] - The company expects to use proceeds from the Backstop Agreement and future debt and equity financings to fund operations[87] Fair Value and Liabilities - The fair value of the Ayrton Note Purchase Option was recorded at $0.3 million initially but was determined to be zero as of December 31, 2023[209] - The Company recorded a liability of $0.5 million for the Ayrton Note Purchase Option, measured using the Black-Scholes Merton model[139] - Total financial liabilities measured at fair value were $68.4 million as of June 30, 2024[180] - The Backstop Put Option Liability had a fair value of $55.9 million as of June 30, 2024[184] - The company measures the fair value of the Backstop Put Option Liability on a recurring basis, with any fair value adjustment recorded within other income (expense)[120] - The company elected to account for the Notes at fair value under the fair value option, with changes in fair value reflected within other income (expense)[130] Legal and Compliance - The company received notices from Nasdaq regarding non-compliance with the timely filing requirement for continued listing[215] - The company filed the delinquent Form 10-K on November 25, 2024 and intends to file the delinquent 10-Qs as soon as practicable[216] - Vellar claims $6.7 million in Maturity Consideration due to alleged failure to register shares[158] Shareholder and Backstop Agreements - The company is obligated to pay the Backstop Parties an amount equal to the product of 8,000,000 shares less Terminated Shares multiplied by $2.50 upon the Maturity Date[112] - The Backstop Parties have purchased a fixed total of 4,885,466 shares of the company's common stock[113] - The Backstop Parties purchased 3,535,466 shares of AHAC's Class A common stock for $10.56 per share, totaling $37.3 million[154] - The Company issued 1,350,000 newly issued shares to Polar at a per share purchase price of approximately $10.56, totaling $14.3 million[154] - The Prepayment amount was $51.6 million, consisting of $37.3 million for the Recycled Shares and $14.3 million for the Polar Subscription shares[155] - Vellar agreed to purchase up to 8,000,000 shares of AHAC's Class A common stock for $80.0 million[161] - The Company has the right to sell up to $75.0 million in newly issued shares to White Lion[168] - The Company received net proceeds of $1.4 million after selling 143,261 Backstop Shares and paying related fees[157] - The Company may issue up to 19,000,000 Earnout Shares to Legacy Ocean Stockholders based on VWAP triggers[151] Other Financial Metrics - Total assets decreased from $5,501 in 2023 to $1,851 in 2024, with a significant reduction in the investment in Virion from $3,392 to $574[63] - Accounts payable and accrued expenses increased to $17,180 thousand as of June 30, 2024, up from $16,185 thousand at December 31, 2023[185] - The Company recognized a loss on extinguishment of debt of $13.6 million for the issuance of the Sponsor Extension Shares[172] - The Company issued 1,365,000 shares of Class A common stock to the Sponsor in consideration for obtaining extensions beyond the September 2022 deadline[148] - The Company issued Converted Ocean Warrants exercisable for 511,712 shares at $8.06 per share and 102,342 shares at $7.47 per share[149] - The Company converted $1.6 million of the Underwriter Promissory Note into 169,582 restricted shares[174] - The Company recorded $0.3 million in interest expense for the six months ended June 30, 2024[173] - The Company has not included future milestone payments in its condensed consolidated balance sheets[30] - AHAC issued approximately 23,355,432 shares of Class A common stock with an aggregate value of $233.6 million to Legacy Ocean's security holders[147] - The company is evaluating the effect of adopting ASU No. 2023-09, which enhances income tax disclosures, effective for fiscal years beginning after December 15, 2024[134] - The company has recorded a full valuation allowance to reduce its net deferred income tax assets to zero, with no provision for income taxes due to operating losses[106]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission File Number: 001-40793 OCEAN BIOMEDICAL, INC. (Exact Name of Registrant as Specified in its Charter) | --- | --- | |------------ ...

Financial Performance and Capital Requirements - The company has incurred significant net losses since inception and is expected to continue incurring substantial net losses for the foreseeable future[22] - The company requires substantial additional capital to finance operations, and failure to raise such capital may delay or reduce research and drug development programs[22] - The company may face increased regulatory costs and compliance requirements in connection with drug development, impacting financial performance[17] Regulatory and Compliance Issues - The company is subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expenses[26] - The company has identified a material weakness in internal control over financial reporting, which may affect the accuracy of financial condition reporting[24] - The company could be subject to investigations by Nasdaq, the SEC, or other regulatory authorities due to control deficiencies[1031] Internal Control and Governance - The company identified a material weakness in internal control over financial reporting due to inadequate staffing in the accounting department[28] - The company plans to hire additional accounting personnel and implement new controls to remediate the identified material weakness[29] - Current and future controls may become inadequate due to changes in business conditions, leading to undiscovered material weaknesses[1030] - Difficulties in developing or maintaining effective controls may negatively impact operating results and reporting obligations[1031] Ownership and Control - The company's principal stockholders and management own a significant percentage of common stock, exerting substantial control over shareholder matters[27] - The company qualifies as an "emerging growth company," which may make its securities less attractive to investors[31] Stock-Based Compensation and Valuation - The company recorded stock-based compensation expense of $0.6 million for the fiscal year ended December 31, 2023, primarily within general and administrative expenses[11] - The estimated fair value of stock options granted to non-employee directors was $3.73 per share, with a strike price of $10.00 per share[11] - The company utilized a Monte-Carlo simulation to value the Backstop Put Option Liability, with an estimated volatility of 100% and a risk-free rate of 4.4%[16] - The fair value of the 2023 Convertible Note was estimated using a Monte-Carlo simulation, with an estimated volatility of 50% and a risk-free rate of 5.3%[17] Segment and Reporting Structure - The company operates as a single reportable segment focused on developing therapeutic products in oncology, fibrosis, infectious diseases, and inflammation[19] - The company early adopted ASU 2020-06, simplifying the accounting for convertible instruments, effective January 1, 2023[21] - The company is evaluating the impact of ASU 2023-07 on its consolidated financial statements, which expands segment disclosures[22] Risks of Financial Reporting - The company may face material weaknesses in internal control over financial reporting, potentially affecting the accuracy and timing of financial reporting[1030] - Failure to remediate existing or future material weaknesses could result in loss of investor confidence and a decline in share price[1030] - A restatement of financial statements for prior periods could occur, potentially causing a decline in the price of common stock and warrants[1031] - The market opportunities for the company's product candidates may be relatively small, targeting patients ineligible for or who have failed prior treatments[22]

Core Insights - Ocean Biomedical has developed a unique oncology platform targeting CHI3L1 to activate natural immune responses against various cancers, including lung cancer, glioblastoma, prostate cancer, melanoma, and breast cancer [1][2][4] Research and Development - New research published in the Journal of Immunology reveals how CHI3L1 inhibits the body's immune responses, particularly macrophage phagocytosis, by activating two key checkpoint pathways [1] - The research indicates that inhibiting CHI3L1 can enhance adaptive immune responses and reduce cancer growth in both standard and humanized mouse models [1][4] Patent and Therapeutic Potential - Ocean Biomedical has received patent allowances for multiple cancers, including prostate, colon, rectal, ovarian, kidney, breast, glioblastoma, melanoma, and lung cancer [2] - The company aims to advance towards IND-enabling studies to develop new cancer therapeutics based on the mechanisms discovered [4] Leadership and Vision - Dr. Jack A. Elias, a leading specialist in pulmonary care and co-founder of Ocean Biomedical, emphasizes the significance of controlling CHI3L1 to manage multiple anti-cancer pathways [3] - The company is focused on addressing unmet medical needs by accelerating the transition of scientific discoveries into therapeutics [6]